Pharma Focus Europe

Eagle Pharmaceuticals Commences Phase 2 Clinical Trial to Evaluate CAL02, a Novel First-in-class Anti-toxin Drug Candidate, for Severe Community-acquired Bacterial Pneumonia (SCABP) Treatment

Monday, July 24, 2023

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) has commenced a Phase 2 study for CAL02, a groundbreaking anti-virulence agent, in severe community-acquired bacterial pneumonia (SCABP) patients. The study aims to assess CAL02's efficacy and safety when administered intravenously alongside standard care, with approximately 276 patients expected to participate across more than 100 sites in over 20 countries. By the end of September, the company plans to have around 50 sites operational, and this number is expected to reach 100 sites by the end of the year to prepare for the global pneumonia season. The first interim report, depending on recruitment rates, is anticipated to be available around the first quarter of 2024.

SCABP remains a significant global infectious disease, leading to high morbidity and mortality despite the availability of vaccines, effective antibiotic regimens, and advanced critical care therapies. CAL02, a first-of-its-kind broad-spectrum anti-virulence agent, aims to counteract bacterial toxins responsible for inflammation, organ damage, and impairing the immune defense. Promising trends for efficacy were observed during the Phase 1 safety and tolerability trial in SCABP patients, and the results were published in The Lancet Infectious Diseases, which described CAL02 as a potential step forward in precision medicine for infectious diseases and hailed the study as a medical breakthrough.

Scott Tarriff, President, and CEO of Eagle Pharmaceuticals, emphasized the need for more effective treatment options for severe bacterial pneumonia, as current antibiotics primarily address the infection but fail to address bacterial virulence factors, which contribute to adverse immunological and inflammatory responses, organ failure, sepsis, and death. CAL02's approach targets common virulence factors produced by the most common pathogens, offering broad utility and potential to elevate the standard of care for severe bacterial pneumonia globally.

Dr. Valentin Curt, Senior VP of Clinical Drug Development and Interim Chief Medical Officer for Eagle Pharmaceuticals, highlighted the persistently high mortality rates in intensive care unit pneumonia patients due to complications even when tissues are pathogen-free and the lungs are clearing. He stressed the significance of addressing virulence factors, which are increasingly recognized as a common denominator in severe, complicated, and resistant bacterial infections. CAL02, as a first-in-class, broad-spectrum, anti-virulence agent, has the potential to mitigate organ damage, pro-inflammatory responses, and facilitate pathogen eradication without contributing to antibiotic resistance, thereby providing critical care and infectious disease physicians with much-needed treatment alternatives.

Eagle Pharmaceuticals believes that CAL02 may be eligible for breakthrough therapy and new chemical entity (NCE) designations. To protect the intellectual property resulting from the development of this innovative therapy, the company is actively developing the patent estate. CAL02 is currently protected by issued U.S. Patent No.10,744,089, with potential extension until 2040, and is also protected in key global markets such as Europe and Japan. Furthermore, multiple pending patent families may provide patent term protection until approximately 2037 or beyond.

In 2021, Eagle Pharmaceuticals entered into a worldwide licensing agreement with Combioxin SA for the commercial rights to CAL02.

CAL02 is an investigational anti-infective agent acting as a competitive decoy for bacterial virulence factors, which contribute to infection-related complications, sepsis, septic shock, and mortality. Its unique action complements antibiotics without inducing selective pressure and potential antibiotic resistance. Based on promising clinical results, CAL02 has the potential to transform the standard of care and significantly reduce the time and cost of treating critically ill SCABP patients. Its versatility and ability to target severe infectious diseases make CAL02 a promising candidate in the fight against antimicrobial resistance.

Virulence factors, produced by various pathogens, play a vital role in infecting hosts and causing diseases. Targeting these factors with anti-virulence drugs has emerged as a new and promising approach in disarming infectious pathogens.

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